The draft guidance describes an optional program where premarket notification submissions could compare the new device against certain FDA defined criteria rather than demonstrating substantial equivalence with comparative testing to a predicate device as has been standard for 510(k) premarket notification submissions.

The purpose is to streamline and expedite submissions of well understood moderate risk devices to reduce regulatory burden.

Background:

This draft guidance describes an alternative 510(k) pathway from the Special 510(k) program and expands the current Abbreviated 510(k) program.

When finalized, the draft guidance on Expansion of Abbreviated 510(k) will be another step towards implementing the least burdensome provisions drafted on December 15, 2017 in response to changes in modern device complexity and the need for modernization of device approval, as described in our blog “FDA Announces Least Burdensome Provisions Draft Guidance”.

Policy:

Section 513(i)(1)(A) of the Federal 99 Food, Drug, and Cosmetic Act (FD&C Act) defines that a device needs to be substantially equivalent with a predicate device for approval through the 510(k) program.

The FDA is permitted to use performance criteria under the FD&C Act to assist in determining substantial equivalence.

Performance criteria could be used to evaluate if a new device performs with equal or greater safety and effectiveness to a predicate device.

A traditional 510(k) direct comparison program would still be available.

Join us in Part 2 of our blog “The FDA Released Draft Guidance for Expanded Abbreviated 510(k) Program” to learn about appropriate use of the Expanded Abbreviated 510(k) program, the FDA’s identification of performance criteria, and data submission to the FDA.